Phase 2
Completed N=100
Memantine in Body Focused Repetitive Behaviors
Trichotillomania (Hair-Pulling Disorder) · Dermatillomania
Source: ClinicalTrials.gov NCT04792645 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: NIMH Symptom Severity Scale (for TTM or Skin Picking) — -1.19; -6.98 units on a scale
Summary
This study is 8 weeks long and involves subjects taking memantine or placebo. If they are randomly assigned to the memantine arm and are eligible to participate in the study, they will begin by taking 10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks. Efficacy and safety measures will be performed at each visit. Participants will be randomized to receive either memantine or placebo on a 1:1 basis. This blinding will be maintained by the IDS pharmacy at the University of Chicago.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NIMH Symptom Severity Scale (for TTM or Skin Picking) |
-1.19; -6.98 | — |
| SECONDARY Clinical Global Impressions-Improvement Scale (CGI-I) |
3; 26 | — |
| SECONDARY Massachusetts General Hospital Hairpulling (Skin Picking) Scale |
-3.09; -6.95 | — |
| SECONDARY Skin Picking Symptom Assessment Scale |
-2.44; -7.00 | — |
| SECONDARY Sheehan Disability Scale |
-1.66; -5.73 | — |
| SECONDARY Hamilton Depression Rating Scale |
-1.31; -2.90 | — |
| SECONDARY Hamilton Anxiety Rating Scale |
-1.42; -3.88 | — |
| SECONDARY Quality of Life Inventory (QOLI) |
2.76; -0.09 | — |
Eligibility Criteria
Inclusion Criteria
- men and women age ≥18 years;
- current DSM-5 trichotillomania or skin picking disorder; and
- Ability to understand and sign the consent form.
Exclusion Criteria
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
- Illegal substance use based on urine toxicology screening
- Stable dose of medications for at least the past 3 months
- Previous treatment with memantine
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Data sourced from ClinicalTrials.gov (NCT04792645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.